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Medtronic Onyx Avm
No active recall
Manufacturer: Medtronic · FDA product code: MFE · Category: Agent, Injectable, Embolic
Severity Snapshot
842 total reports2005-08 – 2026-03 date range15.6% physician / facility reported84.4% manufacturer reported3 SKU variants
Failure & Consequence Profiles
Top Failure Modes
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Top Patient Outcomes
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Reporting Trend
Annual Reporting Volume
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Note: the 2018 Voluntary Malfunction Summary Reporting expansion means volume increases may reflect surveillance changes, not increased device risk.
Reported Events
Submitted to FDA MAUDE by physicians, hospitals, manufacturers, and patients.
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